NCT02049528

Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study

A Phase 1, Open-Label, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Single Oral Doses Of Formulated And Non-Formulated CC-122 Capsules And The Effect Of Food On The Pharmacokinetics Of CC-122 In Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Celgene · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in the study, one for each formulation and one for the test formulation + meal. The subjects will be asked to fast for at least 10 hours before taking the capsule formulations. During one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment sequence which will determine the order in which the subject will receive the reference formulation, the test formulation, and the test formulation + high-fat meal. Blood samples will be taken at intervals during the study to assess the amount of drug at those time points. Blood samples will also be collected at certain time points to determine the levels of special proteins that may help explain how CC-122 work.

Conditions

• Clinical Pharmacology, Healthy Male Volunteer Study

Interventions

Type	Name	Description
DRUG	CC-122	CC-122
DRUG	CC-122	CC-122
DRUG	CC-122	CC-122

Timeline

• Start date: 2014-01-16
• Primary completion: 2014-02-02
• Completion: 2014-02-08
• First posted: 2014-01-30
• Last updated: 2019-11-12

Locations

1 site across 1 country: United States